Industry News

FDA grants 510(k) clearance to Meditech’s new lumbar fusion device

The US Food and Drug Administration (FDA) has granted 510(k) clearance to market spinal implants provider Meditech’s new Talos Lumbar (HA) Peek IBF lumbar fusion device.

The Talos Lumbar (HA) Peek IBF is indicated for use in skeletally mature patients suffering from degenerative disc disease (DDD), which is characterised by the discogenic back pain of the lumbar spine.

The intervertebral body device can be used with autograft and/or allograft of cancellous and/or corticocancellous bone graft in DDD patients with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1.

Along with the new lumbar device, Talos Lumbar Peek devices, which have been in use since 2010, will be marketed in the country with Peek-Optima HA Enhanced material provided by UK-based polymer solutions firm Invibio Biomaterial Solutions.

“With nearly two years of data, we saw enough clinical evidence and heard enough positive surgeon feedback to convince us to move our lumbar portfolio to this new technology.”

Designed to contribute to the interbody fusion process, Peek-Optima HA Enhanced is a new polymer material combined with an osteoconductive material called hydroxyapatite (HA).

Meditech Spine co-founder Eric Flickinger said: “We took a ‘wait and see’ approach with our introduction of HA Peek in our cervical implants in 2015.

“With nearly two years of data, we saw enough clinical evidence and heard enough positive surgeon feedback to convince us to move our lumbar portfolio to this new technology.”

Later this year, the firm intends to release six new lumbar IBF footprints, including Talos-P (HA), Talos-P WB (HA), Talos-T (HA), Talos-TL (HA), Talos-A (HA) and Talos-L (HA), expanding its Talos HA Peek Lumbar System pipeline of interbody devices.